Director, Global Regulatory Information Systems Ultragenyx is a
commercial-stage biopharmaceutical company committed to developing
novel therapies for the treatment of rare and ultra-rare genetic
diseases. The company has rapidly built a diverse portfolio of
small molecule, monoclonal antibody, mRNA and gene therapy
candidates with the potential to address debilitating genetic
diseases for which the unmet medical need is high, the biology for
treatment is clear, and for which there are typically no approved
therapies treating the underlying disease.
Developing new treatments for rare genetic diseases is
challenging work. It takes courage, talent, and dedication to look
past the easy answers and uncover new solutions that can make a
meaningful impact. At Ultragenyx we push each other to perform at
our very best, because we never lose sight of our mission – to make
a difference in our patients’ lives.
Come join our team during this exciting time of growth and
opportunities! During the COVID-19 Outbreak we are committed to our
hiring process. The health and safety of our employees and
prospective employees take priority which means at this time our
process will include WebEx video discussions, interviews &
The Director of Global Regulatory Information Systems leads the
regulatory information management (RIM) program for Ultragenyx
globally (Ultragenyx Pharmaceutical (UGX) and Ultragenyx Gene
Therapy (UGT)). This individual is a strategist, collaborator, and
confident leader that understands the complexities of RIM and is
passionate about driving and delivering meaningful changes to
support our current and future RIM goals.
The position requires a solid understanding of Regulatory
Affairs/Operations and extensive hands-on expertise in Regulatory
specific technology (e.g. InSight Publisher/Viewer and Veeva Vault
RIM), excellent business analysis and project management
This individual collaborates with Global Regulatory Affairs
(UGX/UGT) and other cross-company functions in driving the
development and refinement of our existing and desired global
processes to support a robust RIM program to take Ultragenyx into
This individual will report to the Executive Director,
Regulatory Operations. This role requires outstanding
interpersonal, communication, leadership and collaboration skills
along with the ability to synthesize information and translate it
into meaningful strategy.
Responsibilities: Translate global RIM-related regulations into
meaningful business requirements and solid action plans to support
current and future RIM initiatives over the next 3-5 years.
Provides leadership and subject matter expertise on Regulatory
Responsible for the execution and delivery of Regulatory systems
projects (new implementations, mergers, upgrades, and
Responsible for the daily business administration of Regulatory
systems (e.g. SharePoint, InSight Publisher/Viewer and Veeva Vault
RIM), including (but not limited to) user management, training,
issue escalation and resolution and working with IT and third-party
Drive the development and/or refinement of business process maps
by working cross-functionally to identify future state process
requirements and documentation to support the desired future
Responsible for driving the documentation and revision of all
Regulatory Affairs systems SOPs, and work instructions (WIs) for
Drive the development and updates for training presentations and
other relevant training material for Regulatory systems.
Works collaboratively with IT business partners in the
management of enterprise systems, the development and adherence to
Maintain a robust data foundation across Global Regulatory
Affairs/Operations processes and systems in order to make
information accessible and connected to support regulatory business
Partner with vendors and/or IT business partners in keeping
abreast of technology trends and applicability to business
Collaborates on technology initiatives and applies leadership
skills by working in a global environment with business colleagues
across functional teams including (but not limited to) Clinical,
BioStats, DSPV, and CMC.
Promote a culture of quality, operational excellence and
continuous improvement, supporting company growth.
May manage/mentor direct reports and contractors.
Requirements: Excellent technical understanding and proven,
hands-on experience in technologies such as SharePoint, eCTD
Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and
off-the-shelf and plug-in software such and StartingPoint
Templates, DXC Toolbox that supports the global Regulatory business
and have solid understanding in developing Regulatory requirements,
such as IDMP.
Highly collaborative team player that can communicate clearly to
both technical and non-technical stakeholders to understand
challenges and drive for win-win outcomes.
Exceptional problem solving skills and ability to formulate
innovative solutions that demonstrate both strategic and tactical
Demonstrated ability to organize, prioritize, and execute on
projects to completion.
Proven experience in leading organizational change and
Strong knowledge of control and management of regulatory-focused
content, throughout the product lifecycle stages, SDLC
methodologies and CFR Part 11 and Annex 11 compliance.
Proven experience in staff management, coaching and career
Excellent judgment and interpersonal skills, consensus and
Outstanding presentation skills and professional presence.
Veeva Vault Platform Administrator certification, highly
Bachelor's degree (within a life sciences subject or information
technology) with 8+ yrs experience in Regulatory or Regulatory
technology or equivalent with extensive knowledge of global
regulatory industry initiatives and direction.
Expert in the use of Microsoft Office Suite (Word, Excel, Power
Point, Project, Visio).
#LI-TR1 Ultragenyx Pharmaceutical is an equal opportunity
employer & prohibits unlawful discrimination based on race, color,
religion, gender, sexual orientation, gender identity/expression,
national origin/ancestry, age, disability, marital and veteran
status. Reasonable accommodation will be provided for qualified
individuals with disabilities and for qualified disabled veterans
in job application procedures, as required by applicable law. If
you have any difficulty using our online application system and
need an accommodation due to a disability, you may
contact Talent Acquisition by calling: (415)
483-8800 or by emailing us at
firstname.lastname@example.org . For electronic email and mail
inquiries, please include a description of your requested
accommodation, your name and contact information.
Note to External Recruiters : All candidate activity and open
positions are managed strictly through our Human Resources
Department. Our Human Resources Department kindly requests that
recruiters not contact employees/hiring managers directly in an
attempt to solicit business and present candidates. Please note
that failure to comply with this request will be a factor in
determining a professional relationship with our organization.
Submission of unsolicited resumes prior to an agreement set in
place between the Human Resources Department and the recruiting
agency will not create any implied obligation. Inquiries on
developing a recruiting relationship with us, may be directed to
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